Kornimate/medical-research-clean huggingface dataset:
using practice facilitation and operationalizing referral information technology to increase dsmes utilization

Conditions: Diabetes

Summary: this is a pilot and feasibility study of a pragmatic cluster randomized trial that utilizes health information technology and practice facilitation to address referral barriers and increase clinician awareness and motivation to refer patients with diabetes to diabetes self-management education and services (dsmes).

diabetes self-management education and support (dsmes) is an evidence-based educational program that helps people with diabetes better control their blood sugar (improved hemoglobin a1c) and reduce diabetes-related complications and healthcare costs. dsmes is strikingly underutilized with fewer than 10% of eligible patients receiving this helpful service due to patient-, clinician-, and health system-level barriers that include low clinician awareness and lack of integrated referral processes between clinics and community-based dsmes programs. in this study, we will conduct a pilot and feasibility study of a pragmatic cluster randomized trial that utilizes health information technology and practice facilitation to address referral barriers and increase clinician awareness and motivation to refer patients with diabetes to dsmes. we have partnered with the kentucky department of public health (kdph, statewide dsmes provider), the kentucky regional extension center (ky-rec, practice facilitation partner), and the kentucky health information exchange (health information technology (hit) partner). we will recruit two healthcare systems in rural kentucky to participate in the study. within each healthcare organization, we will randomize control and intervention clusters at the clinic level. clinics in the intervention group will participate in the 12-month intervention which incorporates health information technology and practice facilitation. the health information technology component provides the scaffolding for quality improvement efforts by automating patient identification and enabling bi-directional referral communication between providers and dsmes programs. health information technology support will be available at all clinic sites within participating health care organizations, including the control clinics. the practice facilitation collaborative trains and supports clinical teams to use the model for improvement to make "breakthrough" improvements in diabetes care and dsmes utilization by recognizing barriers and changing clinical systems and care practices.

Eligibility criteria:
inclusion criteria: - clinics are being recruited to participate in the intervention. all clinic staff at participating clinics are eligible for inclusion in the study. exclusion criteria: - there are no exclusion criteria beyond employment at a participating clinic.

Keywords: diabetes self-management education and support (dsmes) implementation science practice facilitation health information technology evidence-based practice rural clinics
focused extracorporeal shock wave therapy (eswt) versus traditional physiotherapy in the treatment of trigger finger

Conditions: Trigger Finger; Stenosing Tenosynovitis

Summary: trigger finger is the common name of stenosing tenosynovitis of fingers, caused by repetitive trauma. conservative treatment includes nsaids or other analgesic agents, activity modification, splint, and physiotherapy. operation could be considered if conservative treatments fails. with literature reviewed, there is no treatment which is both non-invasive and effective, and also could avoid recurrence well. extracorporeal shock wave therapy could induce angiogenesis, anti-inflammatory reaction, and recruitment of fibroblast. although extracorporeal shock wave has been utilized in musculoskeletal diseases for more than twenty years, there is no well-designed clinical trial to prove the effectiveness of extracorporeal shock wave in treating trigger finger. the purpose of this study is to compare the effectiveness of extracorporeal shock wave therapy with traditional physical therapy for the management of trigger finger.


Eligibility criteria:
inclusion criteria: * quinnel classification grade 2 or 3 * who has only one trigger exclusion criteria: * who had ever treated the trigger finger * who has other musculoskeletal disease of the upper limb * who has severe coagulopathy disease * who is pregnant * who has arrhythmia or has a pacemaker * there is sensory impairment, scar, edema at the trigger finger * who has cognitive dysfunction

Keywords: extracorporeal shock wave trigger finger stenosing tenosynovitis
the effect of glucose-insulin-potassium infusion in patients undergoing cardiac surgery

Conditions: Aortic Stenosis; Coronary Heart Disease; Heart Failure

Summary: the purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (gik) during heart surgery.

cardiac surgery with cardiopulmonary bypass and ischemic cardiac arrest is associated with a wide spectrum of perioperative myocardial ischemic-reperfusion injuries resulting in significant cardiac morbidity, namely contractile dysfunction, myocardial infarction, and low cardiac output syndrome requiring prolonged intensive care and hospital stay. the infusion of glucose-insulin-potassium (gik) is one of the oldest cardioprotective interventions during cardiac surgery. although experimental evidence is strong, clinical data remain conflicting. we will investigate the impact of short term gik on the extent of myocardial injuries as well as on the left-ventricular systolic and diastolic function in 2 high-risk groups of cardiac surgical patients: patients with cardiac dysfunction undergoing aortocoronary bypass surgery and patients with severe aortic stenosis.

Eligibility criteria:
inclusion criteria: * severe aortic stenosis * coronary artery disease associated with poor left ventricular function * parsonnet score \>7 exclusion criteria: * dementia or inability to understand the study protocol * off-pump and emergent cardiac surgery * poorly controlled diabetes mellitus * severe renal insufficiency * abnormal liver function child-plugh - c * body mass index \ 35

Keywords: cardiac surgery cardioprotection aortocoronary bypass graft aortic stenosis
prevention of parastomal hernia by primary mesh insertion

Conditions: Parastomal Hernia

Summary: approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. in some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. the use of a mesh as a preventive measure is a safe procedure. this study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.


Eligibility criteria:
inclusion criteria: * permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or hartmann's procedure. exclusion criteria: * asa \> 3 * acute surgery * known immune deficiency * surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months. * pregnancy * known inflammatory bowel disease * lack of written informed consent

Keywords: parastomal hernia onlay mesh sublay mesh pain health questionnaire
study evaluating retinal health monitoring system thickness module

Conditions: Macular Edema; Macular Degeneration

Summary: evaluate the ability and accuracy of the retinal health monitoring system - retinal thickness module (rhms - rtm).

evaluation of the retinal health monitoring system - retinal thickness module in subjects with normal macular thickness and subjects with center-involving macular edema.

Eligibility criteria:
inclusion criteria: 1. corrected visual acuity (va) of 20/100 or better, in the study eye(s) 2. media clarity, undilated pupil size, oct-b scans, axial length measurements in the study eye(s) 3. able to perform self-testing of retinal thickness with the rhms-rtm after training 4. able and willing to give informed consent 5. group 1: 1. macula with normal thickness \[central subfield thickness (cst) below 305 microns as measured by sd-oct\] in at least one eye 2. patients with dry amd are eligible for enrollment into group 1 3. no history of wet amd, dr, or rvo in either eye 6. group 2 and group 3 (in at least one or the same eye): 1. history of center-involving macular edema due to wet amd (group 2); or dr or rvo (group 3) 2. macular edema on sd-oct with cst ≥ 305 microns exclusion criteria: 1. history of corneal refractive surgery, photorefractive keratectomy, radial keratotomy, in the study eye 2. history of epiretinal membrane, vitreomacular traction, or macular hole in the study eye(s) 3. participation in any study using an investigational drug within 30 days or screening or investigational device within 60 days of screening 4. refractive error: spherical equivalent of \> 3 diopters of hyperopia or \> 6 diopters of myopia, or \> 2 diopters cylinder in the study eye(s) 5. history of photocoagulation laser scar or other retinal scar in the central 3 mm of the macula, in the study eye(s)

Keywords: macular edema, wet amd retinal thickness diabetic retinopathy, retinal vein occlusion
osteoporosis treatment protocol in patients with fragility fractures: application and efficacy

Conditions: Osteoporosis

Summary: osteoporosis and osteoporotic fractures, especially hip fractures, have a significant impact on public healthcare. despite the fact that the patients that have suffered an osteoporotic fracture have 86% increased risk of sustaining a second osteoporotic fracture, the efforts to prevent these fractures remain inadequate. the in-hospital initiation of antiosteoporotic treatment in patients that have been admitted due to hip fracture has shown to improve treatment rates and contribute to second fracture prevention. for this purpose the arbeitsgemeinschaft für osteosynthesefragen (ao) foundation has introduced an algorithm that can be used by orthopedic surgeons for the prevention of second fracture in patients that have already suffered an osteoporotic fracture. the purpose of this thesis is to study the efficacy of this algorithm in preventing the second fracture in the greek population. the study will include patients that have been admitted in the orthopedics department of the university hospital of heraklion due to hip fracture. bone density measurement will be performed using the dxa method and antiosteoporotic treatment will be administered according to the algorithm. these patients will be included in the hip registry of the orthopedics department and the follow-up will last for 2 years .the primary aims of the study are: a)evaluation of the adherence to the antiosteoporotic medication b)the efficacy of the adherence to the aforementioned clinical algorithm in the secondary fracture prevention in the greek population.


Eligibility criteria:
inclusion criteria: * patients with hip fractures after low-energy falls(fragility fractures) exclusion criteria: -patients with hip fractures after high energy falls
safety and pharmacokinetics study of human monoclonal antibody (fgi-101-1a6)

Conditions: Influenza

Summary: the purpose of this study is to determine the safety and tolerability of the anti-tsg101 human monoclonal antibody (fgi-101-1a6)when administered intravenously to healthy volunteers.

primary - - to compare the safety profile of a single intravenous administration of fgi-101-1a6 as compared with placebo secondary * to evaluate the pharmacokinetics (pk) of a singel intravenous administration of fgi-101-1a6 * to evaluate the immunogenicity of fgi-101-1a6

Eligibility criteria:
inclusion criteria: * healthy volunteers ages 18-45 * normal laboratory (blood tests) results exclusion criteria: * prior immunization with live-attenuated vaccines

Keywords: influenza antibodies monoclonal virus
tumor control, treatment toxicity, quality of life and bio-imaging repository databank (tq-bird) for cancer patients

Conditions: Cancer

Summary: our central hypothesis is that patient response to treatment, evaluated by full spectrum of outcome measures including tumor control, survival, toxicity, and quality of life (qol), will correlate with biomarker expressions, which can be tested in the blood, other body fluid, imaging as well as tumor tissue (if available).

the primary biomarkers of our interest are those obtained from minimally invasive procedures and those associated with immune/inflammatory treatment responses such as lymphocyte count, immune cell subtype distribution, tgf-beta1, immunomodulating interleukins and ido metabolites. we will measure the biomarkers pre-, during- and post-anticancer treatment for hypothesis driven studies, and bank residual biological specimen, in combination with prospectively collected data including patient/tumor/treatment factors, imaging, tumor control outcome, treatment toxicity and qol measures. we will classify the tumor response according to recist criteria and qualify qol by using the promis grading system and correlate them with the corresponding biomarkers. this study will serve young investigators who are interested in biomarker studies for early diagnosis, tumor control outcome and treatment toxicity/qol prediction, aiming to guide personalized cancer care in future.

Eligibility criteria:
inclusion criteria: cancer patients * 18 years of age and older. * scheduled to receive any kind of therapy in our center. * performance status of ecog 0, 1, 2, or 3. * able to understand qol questionnaire. normal (non cancer) controls * 18 years of age and older healthy volunteers. * without a history of cancer except for cured skin cancer, without any active cancer. * ecog performance status 0, 1, 2, or 3. exclusion criteria: participants who have supposedly limited ability to complete the survey questionnaires of the present study will be excluded.

Keywords: surgery systemic therapy radiotherapy biomarker imaging toxicity quality of life
tenecteplase reperfusion in acute ischemic stroke registry（treat）

Conditions: Stroke, Ischemic

Summary: the aim of the study was to establish tenecteplase thrombolysis database and to investigate the effectiveness and safety of rhtnk-tpa in acute ischemic stroke patients.

tenecteplase (tnk), as a newer fibrinolytic agent, has practical delivery advantages over alteplase that would make it a potential alternative. several randomized controlled clinical trials demonstrated the noninferiority of tnk but the evidence on the effectiveness and safety of tnk in the real-world is insufficient. this is a multi-center, prospective, registry cohort study that enrolled acute ischemic stroke patients treated with tnk thrombolysis in china.

Eligibility criteria:
inclusion criteria: * older than 18 years; * diagnosed as acute ischemic stroke； * time intervals ≤ 4.5 hours from stroke onset to thrombolysis with tnk(perfusion imaging completed including cta+ctp or mra+pwi+dwi before thrombolysis if the time intervals from stroke onset to thrombolysis was ≥4.5 hours)； * thrombolysis with rhtnk-tpa and derivatives. exclusion criteria: * unlikely to adhere to the study protocol or follow-up ( life expectancy ≤ 3 months)； * already participated in other interventional trials.

Keywords: thrombolysis tenecteplase
trial to assess the efficacy and safety of nafamostat mesilate during continuous renal replacement therapy

Conditions: Acute Kidney Injury

Summary: randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.

patients were randomly assigned to the nafamostat mesilate (nm) group or the no anticoagulant (na) group. in patients assigned to the nm group, nm (20mg/h) was used for maintenance anticoagulation. whereas, in patients assigned to the na group, normal saline (2ml/h) was infused for continuous renal replacement therapy.

Eligibility criteria:
inclusion criteria: * patients who were admitted to the intensive care unit and required crrt 1. active bleeding such as gastrointestinal bleeding and intracranial hemorrhage, 2. activated partial thromboplastin time \> 60 s, 3. prothrombin time-international normalized ratio \> 2.0, 4. thrombocytopenia (\<100,000/µl), and 5. surgery within 48 h before crrt. exclusion criteria: * pregnant or possibly pregnant women * patients who were allergic to nafamostat mesilate * patients who were hypercoagulable
comparison of the treatments of obinutuzumab + venetoclax versus obinutuzumab + chlorambucil in patients with chronic lymphocytic leukemia

Conditions: Lymphocytic Leukemia, Chronic

Summary: this open-label, multicenter, randomized phase iii study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (cll) and coexisting medical conditions. the time on study treatment was approximately one year and the follow-up period will be up to 9 years


Eligibility criteria:
inclusion criteria: * documented previously untreated cll according to the international workshop on chronic lymphocytic leukemia (iwcll) criteria * cll requiring treatment according to iwcll criteria * total cumulative illness rating scale (cirs score) greater than (\>) 6 * adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of cll * adequate liver function * life expectancy \> 6 months * agreement to use highly effective contraceptive methods per protocol exclusion criteria: * transformation of cll to aggressive non-hodgkin's lymphoma (richter's transformation or pro-lymphocytic leukemia) * known central nervous system involvement * participants with a history of confirmed progressive multifocal leukoencephalopathy (pml) * an individual organ/ system impairment score of 4 as assessed by the cirs definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system * participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia * inadequate renal function * history of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy * use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration * participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products * hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients * pregnant women and nursing mothers * positive test results for chronic hepatitis b virus (hbv) infection (defined as positive hepatitis b surface antigen \[hbsag\] serology) or positive test result for hepatitis c (hepatitis c virus \[hcv\] antibody serology testing) * participants with known infection with human immunodeficiency virus (hiv) or human t-cell leukemia virus-1 (htlv-1) * requires the use of warfarin, marcumar, or phenprocoumon * received agents known to be strong and moderate cytochrome p450 3a inhibitors or inducers within 7 days prior to the first dose of study drug
the effects of anti-hiv drugs on the hiv virus in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to examine the hiv virus in the blood and lymphoid tissues of patients taking anti-hiv medications. hiv infection is closely linked to the growth of the hiv virus in the body. much of this information was obtained from studying how the hiv virus grows in circulating blood. recent studies have shown that the lymphoid tissue (part of the immune system) is a major site where hiv is found in the body and is also where much of the hiv virus growth occurs. this study will examine not only blood but also lymphoid tissue to gain a better understanding of the disease and how to treat it.

the natural history and pathogenesis of hiv-1 infection are linked closely to the replication of virus in the body. studies obtained entirely from analyses of peripheral blood led to a shift in the understanding of hiv-1 pathogenesis. recent studies have shown that lymphoid tissues are a major reservoir for hiv and the primary site of virus replication. the proposed studies will provide the first comprehensive assessment of hiv-1 expression and lymphocyte response in both blood and lymphocyte tissue compartments. the data obtained will provide new insight into hiv-1 pathogenesis and provide a more rational basis for treatment decisions concerning early therapy of hiv-1 infection. patients are admitted to the hospital for insertion of an angiocath to collect blood samples periodically over 48 hours on the day study medication from the parent study is initiated. after discharge, additional blood samples are obtained over a 6-month period. within 7 days prior to a scheduled biopsy, patients have physical examinations and laboratory evaluations done. all patients undergo some combination of the following during the 2-week prestudy evaluation period and at weeks 4 and 24: a) superficial lymph node biopsy from cervical, axillary, or inguinal area; b) rectal biopsy; and/or c) tonsillar biopsy. the tissue samples provide an assessment of viral and cellular dynamics.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are at least 18 years old. * are participants in other university of alabama studies. exclusion criteria patients will not be eligible for this study if they: * are pregnant. * are receiving treatment for an aids-defining opportunistic infection, other than preventive treatment.

Keywords: lymphocytes hiv-1 lymphoid tissue blood anti-hiv agents viral load